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Hodgkin's LymphomaPhase 1NCT01884428

Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma

A Phase 1 study testing panobinostat, Ifosfamide and Gemcitabine in people with Hodgkin's Lymphoma, run by Armando Santoro, MD at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
panobinostat, Ifosfamide and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
Jul 2011to Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of relapsed or refractory classical HL
  • Measurable disease
  • One or two prior systemic lines of treatment
  • PS(ECOG) 0-2
  • Absence of bone marrow infiltration
  • Adequate laboratory values for bone marrow, liver and renal functionality

Who cannot join

  • prior or concurrent treatment with a DAC inhibitor including panobinostat
  • valproic acid therapy for any medical condition during the study or within 5 days prior to the first panobinostat treatment
  • previous autologous hematopoietic stem cell transplant
  • other concurrent therapy intended to treat the primary cancer including chemotherapy, investigational or biologic agents or other antitumor agents
  • impaired cardiac function or unstable AF
  • known history of HIV seropositivity, chronic hepatitis, or other active viral infections
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  • pregnant or breast feeding women

Trial locations and contacts

1 site in 1 country.

Armando Santoro, MD contact

+39 (0)2 8224 ext. 4080

armando.santoro@humanitas.it

Rita Mazza, MD contact

+39 (0)2 8224 ext. 4780

rita.mazza@humanitas.it

Italy1 site, 1 recruiting

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

    Armando Santoro, MD, +39 (0)2 8224 ext. 4080, armando.santoro@humanitas.it

    Rita Mazza, MD, +39 (0)2 8224 ext. 4780, rita.mazza@humanitas.it

    Recruiting

Other trials in Italy

About this study

Official title: Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma

study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

Read the detailed description

Patients will received 4 p-IGEV courses repeated every 3 weeks in the absence of unacceptable toxicity, whenever an objective response is observed at disease evaluation performed after II cycle.

Eligible patients will be accrued in cohorts of 3 patients at each dose level and dose escalation will be performed following the standard 3+3 rule.

Three patients will be treated for each dose-level, starting from level 1, for one cycle: if no dose-limiting toxicities (DLTs) will be recorded after the first cycle, treatment will be continued in those patients until study completion or unacceptable toxicity and three new patients will be treated at the next dose level. However, if one out of 3 patients will develop a DLT, the same dose-level will be administered to three additional patients for one cycle. If no one of those additional patients will experience a DLT, dose escalation will continue. If more than one over 3 or 6 patients will develop a DLT after the first cycle in any cohort, MTD will be reached. Six further patients will be treated at the lower dose in order to obtain more information about the optimal dose for phase II trials and to characterize pharmacokinetic profiles of this combination. If DLT will be found at level 1 (20 mg), 3 patients will be treated at dose -1 (10 mg). If no more than 1 patient experience toxicity, other 3 patients will be treated to assess more information about pharmacokinetic profiles and safety.

Being tested
panobinostat, Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone
Keywords
Hodgkin, Lymphoma
Medical subject headings
Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panobinostatDrug

    Also called LBH-589

    Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration

  • IfosfamideDrug

    Also called Ifex

    Ifosfamide 2000 mg/m2 on days 1 to 4 as a 2-hour infusion for a maximum of 4 cycles of three weeks duration

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration

  • VinorelbineDrug

    Also called Navelbine

    Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration

  • PrednisoloneDrug

    Also called Prelone

    Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration

Study groups in NCT01884428
Study groupRoleWhat they receive
Panobinostat + IGEVExperimentalPanobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)
Receives: Drug: panobinostat; Drug: Ifosfamide; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) or the recommended phase II dose defined as the highest dosage cohort at which no more than one of six patients will experience a DLT in the first treatment cycle.

    Measured: 3 weeks

Secondary outcomes (6)

  1. DLT

    Incidence of dose limiting toxicities (DLTs)

    Measured: 3 weeks

  2. safety profile

    Preliminary safety profile defined as Adverse Events (AEs), Serious Adverse Events ( SAEs) \& Changes in Clinical Laboratory Evaluations

    Measured: 3 months

  3. Complete Response and Overall Response Rate

    Measured: 3 months

  4. hematologic toxicity

    Assessment of neutropenia and thrombocytopenia incidence, duration, as well as platelet transfusion requirement

    Measured: 3 months

  5. CD34+ cells count

    Assessment of number of CD34+ collected and number of leukapheresis required to obtain an appropriate collection according to transplant program.

    Measured: 3 months

  6. efficacy of PIGEV combination in terms of progression-free survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2014 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01884428
Sponsor's protocol ID
ONC-2010-003
Other IDs
2010-022452-23
Status last verified
Jan 2014
First submitted
27 May 2013
Last updated
29 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing panobinostat, Ifosfamide and Gemcitabine in people with Hodgkin's Lymphoma, run by Armando Santoro, MD at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Armando Santoro, MD (+39 (0)2 8224 ext. 4080, armando.santoro@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) or the recommended phase II dose defined as the highest dosage cohort at which no more than one of six patients will experience a DLT in the first treatment cycle. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01884428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.

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